Novartis Pharma Schweiz AG seeks a Senior Expert in Device Project Leadership for its Global Device and Packaging Development team, focusing on Cell & Gene Therapy and Radioligand Therapy projects in Basel.
This position sits within the Portfolio & Customer Center of the Global Device and Packaging Development (GDPD) group. The role primarily supports initiatives in Cell & Gene Therapy (C>) and Radioligand Therapy (RLT), serving as the central contact for all device and packaging matters while ensuring strategic alignment and regulatory compliance.
Responsibilities
- Act as the primary liaison for GDPD within CMC sub-teams, guiding device-related discussions and obtaining approval for project strategies or modifications.
- Direct cross-functional project teams and serve as the single point of contact for all device and packaging inquiries.
- Oversee project planning, including the management of resources, timelines, and financial budgets.
- Continuously evaluate and negotiate the need for internal and external resources.
- Create and maintain high-quality documentation, including the Design History File, for combination product developments and lifecycle management projects.
- Ensure adherence to internal processes and current regulations, such as Design Control, CMC, FDA combination product rules, and ISO standards.
- Participate in enhancing process and delivery technology methods.
- Assess appropriate device technologies to support various project stages.
- Provide support for internal and external audits concerning packaging and medical device compliance.
- Assist in preparing regulatory dossiers, including documents for medical device or combination product registration, and address health authority queries.
Requirements
- Master’s degree or PhD in natural sciences, engineering, pharmaceuticals, or a comparable field.
- At least 2 to 4 years of experience in the pharmaceutical sector.
- Demonstrated ability to lead cross-functional teams within a matrix organization.
- Strong background in project and program planning and execution.
- Solid understanding of regulatory guidelines for drug-device combination products, including relevant ISO standards and current good manufacturing practices (cGMP).
- Fluent proficiency in English, both written and spoken.
Nice to have
- PhD degree.
- Experience with C> and RLT, as well as technical development of drug-device combination products.
- German language skills.
What the company offers
- Performance-based bonus tied to specific performance metrics.
- Comprehensive insurance plans.
- Retirement plans.
- Wellbeing resources.
- Global recognition programs.
- Flexible and hybrid working options, where possible.
- Minimum 14 weeks paid parental leave.
About the company
Novartis Pharma Schweiz AG is dedicated to reimagining medicine together, fostering a collaborative environment focused on innovative healthcare solutions.
- Commitment to reimagining medicine together.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.